Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
- Registration Number
- NCT00522834
- Lead Sponsor
- Synta Pharmaceuticals Corp.
- Brief Summary
"Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals.
Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.
One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 630
- Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
- ECOG performance status of <=2
- Measurable disease according to modified RECIST
- Life expectancy of greater than 12 weeks
- LDH <= 2.0 x ULN
- Clinical lab values within protocol parameters.
- At least 18 years old and able and willing to provide informed consent to participate
- Previous cytotoxic chemotherapy treatment for melanoma
- Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
- Presence of brain metastases
- Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
- Female subjects who are pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Elesclomol (STA-4783) Elesclomol (STA-4783) in Combination With Paclitaxel 2 Paclitaxel Paclitaxel alone
- Primary Outcome Measures
Name Time Method Progression free survival June 2009
- Secondary Outcome Measures
Name Time Method Overall Survival December 2009 Clinical benefit rate December 2009 Safety December 2009 Pharmacokinetics December 2009 Objective response rate December 2009 Duration of objective response December 2009
Trial Locations
- Locations (99)
The Ohio State University.
🇺🇸Columbus, Ohio, United States
Cancer Pavilion
🇺🇸Pittsburgh, Pennsylvania, United States
University of California San Diego Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Goshen Center for Cancer Care
🇺🇸Goshen, Indiana, United States
Monter Cancer Center North Shore Hospital
🇺🇸Lake Success, New York, United States
Leo W. Jenkins Cancer Center
🇺🇸Greenville, North Carolina, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Jonsson Comprehensive Cancer Center Univ. of California Los Angeles
🇺🇸Los Angeles, California, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Redwood Regional Medical Group
🇺🇸Santa Rosa, California, United States
Carolina Hematology & Oncology Associates
🇺🇸Charlotte, North Carolina, United States
Ellis Fischels Cancer Center
🇺🇸Columbia, Missouri, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Princess Alexandra Hospital
🇦🇺Wooloongabba, Queensland, Australia
Brody School of Medicine at East Carolina State University
🇺🇸Greenville, North Carolina, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Stony Brook University Medical Center- Cancer Center
🇺🇸Stony Brook, New York, United States
Lismore Base Hospital, Cancer Care & Haematology Unit
🇦🇺Lismore, New South Wales, Australia
Newcastle Melanoma Unit - Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
Hospital Universitario de la Princessa Servicio de Oncología Médica
🇪🇸Madrid, Spain
Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital
🇷🇴Timisoara, Romania
VA Medical Center
🇵🇷San Juan, Puerto Rico
Northern Centre for Cancer Treatment Newcastle General Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Hubert H. Humphrey Cancer Center
🇺🇸Robbinsdale, Minnesota, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
The Angeles Clinic & Research Institute
🇺🇸Los Angeles, California, United States
Bay Pines VA Healthcare System
🇺🇸Bay Pines, Florida, United States
Emory University Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Rush University Hospital
🇺🇸Chicago, Illinois, United States
Oncology Specialists, S.C.
🇺🇸Niles, Illinois, United States
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
Joliet Oncology/Hematology Associates, LTD
🇺🇸Joliet, Illinois, United States
Oncology Specialists, SC
🇺🇸Park Ridge, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Mark H. Zangmeister Cancer Center
🇺🇸Columbus, Ohio, United States
Abramson Cancer Center at University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
St. Luke's Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
Texas Oncology, PA
🇺🇸Dallas, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Southern Medical Day Care Centre
🇦🇺Wollongong, New South Wales, Australia
Redcliffe Hospital
🇦🇺Redcliffe, Queensland, Australia
Royal Adelaide Cancer Centre Medical Oncology
🇦🇺Adelaide, Australia
Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital
🇦🇺North Sydney, Australia
The Tweed Hospital
🇦🇺Tweed Heads, Australia
Department of Medical Oncology, Westmead Hospital
🇦🇺Westmead, Australia
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Northeastern Ontario Regional Cancer Centre
🇨🇦Sudbury, Ontario, Canada
Univ. of Miami Hospital and Clinics
🇺🇸Miami, Florida, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Cross Cancer Institute
🇨🇦Edmonton, Canada
Princess Margaret Hospital
🇨🇦Toranto, Canada
Vivantes Klinikum Im Friedrichshain
🇩🇪Berlin, Germany
Vivantes Klinikum Neukölln
🇩🇪Berlin, Germany
Elbe-Klinikum Buxtehude
🇩🇪Buxtehude, Germany
University Frankfurt
🇩🇪Frankfurt/Main, Germany
University of Kiel
🇩🇪Kiel, Germany
Universität zu Köln
🇩🇪Köln, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Oncology Institute "Prof. Dr. Ion Chiricuta"
🇷🇴Cluj Napoca, Romania
Clinical County Hospital " Alexandru Simionescu" Hunedoara
🇷🇴Hunedoara, Romania
Clinical County Hospital Sibiu
🇷🇴Sibiu, Romania
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos
🇪🇸Toledo, Spain
Oncology Centre Addenbrookes's Hospital
🇬🇧Cambridge, United Kingdom
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
San Antonio Cancer Institute
🇺🇸San Antonio, Texas, United States
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Anschutz Cancer Pavillion University of Colorado
🇺🇸Aurora, Colorado, United States
Atlantic Health Research - Mountainside Hospital
🇺🇸Montclair, New Jersey, United States
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
QE II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Winthrop P. Rockefeller Cancer Institute
🇺🇸Little Rock, Arkansas, United States
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Southeast Nebraska Hematology/Oncology
🇺🇸Lincoln, Nebraska, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cancer Center of the Carolinas
🇺🇸Greenville, South Carolina, United States
Hematology Oncology, P.C.
🇺🇸Stamford, Connecticut, United States
County Hospital Brasov - Oncology Department
🇷🇴Brasov, Romania
Center of Medical Oncology
🇷🇴Iasi, Romania
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Dorset Cancer Centre Poole Hospital NHS Foundation Trust
🇬🇧Poole, United Kingdom
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Weill Medical College of Cornell University - Division of Hematology and Medical Oncology
🇺🇸New York, New York, United States
NYU Clinical Cancer Center
🇺🇸New York, New York, United States
Pacific Medical Center Research Institute
🇺🇸San Francisco, California, United States
MD Anderson Cancer Center
🇺🇸Orlando, Florida, United States
Karmanos Cancer Institute, Wayne State University
🇺🇸Detroit, Michigan, United States
Nebraska Methodist Cancer Center
🇺🇸Omaha, Nebraska, United States
UNC School of Medicine - Division of Hematology/Oncology
🇺🇸Chapel Hill, North Carolina, United States
Derrick L. Davis Regional Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Providence Cancer Center Clinical Trials
🇺🇸Portland, Oregon, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States